Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
CCX168 · 7 trials · 4 indications
The mean change in the slope of the urinary protein:creatinine ratio (UPCR, in mg/g/week) between the 8-week run-in period and the 12-week treatment period
Acronyms use: Adverse Events (AE's) Serious Adverse Events (SAE's)
Acronyms use: Adverse Events (AE's) Serious Adverse Events (SAE's)
Disease response is defined as BVAS percentage reduction from baseline of at least 50% plus no worsening in any body system component.
| Arm | Type | Description |
|---|---|---|
| CCX168 (Avacopan) | EXPERIMENTAL | CCX168 (Avacopan) plus stable dose of RAAS blocker |
| Placebo | PLACEBO_COMPARATOR | Placebo plus a full dose of oral glucocorticoids for steps 1 and 2 of the study |
| CCX168 | EXPERIMENTAL | 30 mg Active study medication, plus either two-thirds reduced dose of oral glucocorticoids for step 1 of the study, or no oral glucocorticoids for step 2 of the study |
| Cohort A: Single Oral Dosing of CCX168 in Japanese Adult Males | EXPERIMENTAL | Healthy Japanese adult males will receive 1 of 3 single oral doses of CCX168 (10 mg, 30 mg or 100 mg) or placebo. Each dose level will be administered under fasted conditions. Single doses of CCX168 30 mg will be administered under fasted and fed conditions. |
| Cohort B: Multiple Oral Dosing of CCX168 in Japanese Adult Males | EXPERIMENTAL | Healthy Japanese adult males will receive 1 of 2 oral doses of CCX168 (30 mg or 50 mg) or placebo twice-daily for 7 days under fed conditions. |
| Cohort C: Single Oral Dosing of CCX168 in Caucasian Adult Males | EXPERIMENTAL | Healthy Caucasian adult males will receive 1 of 2 single oral doses of CCX168 (10 mg or 30 mg) or placebo under fasted conditions. |
| Cohort D: Multiple Oral Dosing of CCX168 in Caucasian Adult Males | EXPERIMENTAL | Healthy Caucasian adult males will receive an oral dose of CCX168 30 mg or placebo twice-daily for 7 days under fed conditions. |
| Cohort A | EXPERIMENTAL | A single dose of 2 mg midazolam (a Cytochrome P450 \[CYP\]3A4 probe drug) and a single dose of 200 mg celecoxib (a CYP2C9 probe drug) will be given orally concurrently on Day 1 and Day 13. On Day 3 through Day 18, CCX168 will be given orally at 30 mg twice daily (b.i.d.), and a single dose of 30 mg CCX168 will be given in the morning on Day 19. On Day 16 through Day 19, a once daily (q.d.) dose of 200 mg itraconazole (a CYP3A4 inhibitor) will be given orally. |
| Cohort B | EXPERIMENTAL | A single dose of 30 mg CCX168 will be given on Day 1 and Day 14, while rifampicin (a CYP3A4 inducer) will be given at 600 mg once daily from Day 4 through Day 17. |
| Cohort 1: Sequence ABCD | EXPERIMENTAL | Participants assigned to sequence ABCD will receive the following treatments: Period 1: Single dose of 30 mg CCX168 after a high-fat, high-calorie meal (Treatment A). Period 2: After a washout period of ≥ 10 days, single dose of 30 mg CCX168 in the fasted state (Treatment B). Period 3: After a washout period of ≥ 10 days, single dose of 3 mg CCX168 in the fasted state (Treatment C). Period 4: 24 hours after the 3 mg CCX168 dose in Period 3, single dose of 100 mg CCX168 on Day 1, and then 100 mg CCX168 twice daily from Day 2 through Day 6. On Day 7, only a morning dose of 100 mg CCX168 (Treatment D). |
| Cohort 2: Sequence BACD | EXPERIMENTAL | Participants assigned to sequence BACD will receive the following treatments: Period 1: Single dose of 30 mg CCX168 in the fasted state (Treatment B). Period 2: After a washout period of ≥ 10 days, single dose of 30 mg CCX168 after a high-fat, high-calorie meal (Treatment A). Period 3: After a washout period of ≥ 10 days, single dose of 3 mg CCX168 in the fasted state (Treatment C). Period 4: 24 hours after the 3 mg CCX168 dose in Period 3, single dose of 100 mg CCX168 on Day 1, and then 100 mg CCX168 twice daily from Day 2 through Day 6. On Day 7, only a morning dose of 100 mg CCX168 (Treatment D). |
| [14C]CCX168 | EXPERIMENTAL | Participants will receive a single oral dose of \[14C\]CCX168 100 mg containing 400 μCi of \[14C\] on Day 1. |
| Cohort 1 | EXPERIMENTAL | During Period 1, participants will receive a single dose of CCX168 1 mg or placebo. During the second study period, participants will receive the same dose as during the first period but once daily (QD) for a period of 7 days continuously. |
| Cohort 2 | EXPERIMENTAL | During Period 1, participants will receive a single dose of CCX168 3 mg or placebo. During the second study period, participants will receive the same dose as during the first period but QD for a period of 7 days continuously. |
| Cohort 3 | EXPERIMENTAL | During Period 1, participants will receive a single dose of CCX168 10 mg or placebo. During the second study period, participants will receive the same dose as during the first period but QD for a period of 7 days continuously. |
| Cohort 4 | EXPERIMENTAL | During Period 1, participants will receive a single dose of CCX168 30 mg or placebo. During the second study period, participants will receive the same dose as during the first period or placebo twice daily (BID) for a period of 7 days continuously. |
| Cohort 5 | EXPERIMENTAL | During Period 1, participants will receive a single dose of CCX168 100 mg or placebo. During the second study period, participants will receive the same dose as during the first period or placebo BID for a period of 7 days continuously. |
| Name | Type | Description |
|---|---|---|
| CCX168 | DRUG | CCX168 30 mg, twice daily (b.i.d.) orally for 84 days (12 weeks). The CCX168 dose was taken in the morning, optimally within one hour after breakfast, and in the evening, optimally within one hour after dinner. |
| Placebo | DRUG | BID for 84 days |
| Midazolam | DRUG | Administered orally. |
| Celecoxib | DRUG | Administered orally. |
| Itraconazole | DRUG | Administered orally. |
| Rifampicin | DRUG | Administered orally. |
| [14C]CCX168 | DRUG | Administered orally. |
Key Inclusion Criteria: * Diagnosis of Immunoglobulin A nephropathy * estimated glomerular filtration rate \>60 mL/min/1.73 m2 * Proteinuria (first morning urinary protein:creatinine ratio \>1g/g creatinine) Key Exclusion Criteria: * Severe renal disease * Pregnant or nursing * Proteinuria \>8g/g...
CCX168 is an investigational small molecule being developed for the treatment of vasculitis, including anti-neutrophil cytoplasmic antibody-associated vasculitis, and immunoglobulin A nephropathy. It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.
CCX168 is being developed by Amgen Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol AMGN. The drug is currently in Phase 1 clinical trials, with all four completed studies conducted in healthy volunteers.
CCX168 is in Phase 1 clinical development. All four clinical trials associated with the drug have been completed, with a total enrollment of 134 participants. The drug is investigational and has not received regulatory approval for any indication.
CCX168 has completed four Phase 1 clinical trials. These include NCT05988008, a study in Japanese and Caucasian healthy adult males; NCT05988021, evaluating food effect and cardiac safety; NCT06004947, assessing drug-drug interactions; and NCT06004960, a mass balance study. All trials enrolled healthy volunteers.
CCX168 is also known as avacopan. The drug is being studied for conditions including anti-neutrophil cytoplasmic antibody-associated vasculitis and immunoglobulin A nephropathy. It is currently in Phase 1 development by Amgen Inc.